Nutrition Intervention in AIDS Wasting

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ClinicalTrials.gov Identifier: NCT00006167

Recruitment Status :
Completed

First Posted : August 9, 2000

Last Update Posted : January 13, 2010

Sponsor:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Information provided by:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

There are no guidelines for appropriate nutritional management of weight loss or wasting in HIV infection. Some treatments may increase weight, but without improving muscle mass or quality of life. In this clinical trial AIDS patients with wasting are randomized to one of three nutritional strategies and studied over a 12-week period: 1) optimal oral nutrition with counseling and protein and calorie supplementation, and a placebo pill; 2) optimal oral nutrition with the oral androgen, oxandrolone at 20 mg daily; and 3) optimal oral nutrition with progressive resistance training (PRT). In all participants, dietary intervention is maximized by weekly personalized counseling to address individual issues and concerns. Two primary outcomes are assessed: thigh muscle mass and quality of life. Our findings can be used to develop guidelines for standards of nutritional care among AIDS patient with the wasting syndrome.

Detailed Description

Not Provided

Study Type ICMJE

Interventional

Study Phase

Phase 4

Study Design ICMJE

Masking: DoublePrimary Purpose: Treatment

Condition ICMJE

HIV Wasting Syndrome

Intervention ICMJE

Drug: oxandrolone

Behavioral: Progressive Resistance Training

Study Arms

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ICMJE

Completed

Enrollment ICMJE

Not Provided

Original Enrollment ICMJE

Not Provided

Study Completion Date

August 2000

Primary Completion Date

Not Provided

Eligibility Criteria ICMJE

Inclusion Criteria:

Loss of 10% of usual body weight, OR loss of 5% of usual body weight within the previous 6 months, OR BMI20kg/m2. If the candidate is taking a protease inhibitor, he/she must have not regained weight since initiating the medication over a period of at least 4 weeks prior to screening.

Documented HIV-positive

Able to eat

English-speaking

Compliance with medical regimens

For heterosexually active women: willingness to use an effective means of birth control

Patient and physician not planning to start new treatments for HIV infection or weight loss during the 12 weeks of study.

Exclusion Criteria:

Vomiting 1 time/day or diarrhea 4 times/day on average in the previous week

Fever 101 F within the previous week

Receiving induction treatment for one of the following (new diagnosis or recurrence within 4 weeks):